Sterile Compounding

To provide increased oversight and better safeguards for compounded pharmaceuticals, new state and federal standards and regulations are on the horizon. Both the California Board of Pharmacy and the United States Pharmacopeia (USP) Convention have instituted significant changes that could affect hospitals’ physical pharmacy plant space and engineering controls. CHA’s Medication Safety Committee has advocated for state regulations that closely match USP standards and protect public safety, as well as leverage patient care delivery needs and diverse hospital resources across the state. Hospitals are encouraged to review the new and proposed changes, perform a gap analysis and mitigate a plan to meet federal and state requirements.

At right are several tools hospitals might find helpful: a high-level assessment tool for identifying compliance gaps; frequently asked questions; and a set of grids describing the specific Board of Pharmacy and USP requirements and timelines.

To provide increased oversight and better safeguards for compounded pharmaceuticals, new state and federal standards and regulations are on the horizon. Both the California Board of Pharmacy and the United States Pharmacopeia (USP) Convention have instituted significant changes that could affect hospitals’ physical pharmacy plant space and engineering controls. CHA’s Medication Safety Committee has advocated for state regulations that closely match USP standards and protect public safety, as well as leverage patient care delivery needs and diverse hospital resources across the state. Hospitals are encouraged to review the new and proposed changes, perform a gap analysis and mitigate a plan to meet federal and state requirements.

At right are several tools hospitals might find helpful: a high-level assessment tool for identifying compliance gaps; frequently asked questions; and a set of grids describing the specific Board of Pharmacy and USP requirements and timelines.

In January 2017, the California Board of Pharmacy (BoP) established new requirements for hospitals performing sterile compounding. In addition, the Office of Statewide Health Planning and Development’s Facilities Development Division and the California Department of Public Health (CDPH) Licensing and Certification Program must review physical plant and program changes that hospitals must make to comply with the new BoP requirements.

In May, CDPH released an All Facilities Letter clarifying requirements for new or remodeled pharmacy clean rooms and use of mobile sterile compounding units in general acute care hospitals. According to the letter, hospitals must obtain CDPH approval for all new or remodeled pharmacy clean rooms under the hospital’s license. Hospitals must also obtain CDPH approval — including program flexibility approval — to temporarily use mobile sterile compounding units. CDPH advises hospitals to submit applications to the Centralized Applications Unit 120 days prior to when they anticipate completion of the new or remodeled pharmacy, and to clearly mark that the application is for sterile compounding. In addition, CDPH advises hospitals to contact the CDPH Pharmacy Consultant Unit at LNCPharmCleanRoom@cdph.ca.gov 90 days prior to anticipated completion.

The United States Pharmacopeial Convention (USP) is revising its 797 standard, which governs sterile preparation spaces for pharmaceutical compounding. USP received more than 8,000 comments on the rule from more than 2,500 stakeholders from Sept. 25, 2015, to Jan. 31, 2016.

Based on the number of comments, USP will publish the revised chapter for a second round of public comments before issuing the final standard. At this time, USP does not have an anticipated date for the chapter’s republication.

Overview

Effective January 2017, hospitals that perform sterile compounding must meet new regulatory requirements from the California State Board of Pharmacy. Beyond updating processes and procedures, hospitals will be required to improve or reconfigure facilities for ventilation, install new equipment for sterility and ensure employee protections.